FDAClass II · Drug · Recall D-0484-2026 · Recalled April 29, 2026

Pantoprazole Sodium recall — Hetero Labs Limited (Unit V)

Agency report date: April 29, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: Pantoprazole Sodium
Company / brand: Hetero Labs (Unit V)
Lot / serial / date codes: Batch # FD253967, Exp Date: 06/26/2027
Distribution: Nationwide in the USA.

Agency product description and boundaries

Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherta, Mahabubager-509 301, India, NDC 31722-713-10

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: Pantoprazole Sodium recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: D-0484-2026
Brand: All Hetero Labs (Unit V) recalls
Classification: Class II
Units affected: 4,740 1,000-count bottles.
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

Pantoprazole Sodium recall status

Companies & origin

Recalling firm location: Mahabubnagar, N/A, India
Firm address: Unit V, Sy. No.: 439,440,441&458, Tsiic Formulation Sez, Polepally Village, N/A

Identifying details (verbatim from the notice)

Product codes / lots: Batch # FD253967, Exp Date: 06/26/2027
Distribution: Nationwide in the USA.
Firm notified the public via: N/A
FDA event ID: 98671
Recall initiated: March 26, 2026
FDA classified: April 17, 2026
FDA report date: April 29, 2026

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Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved July 28, 2026 at 11:00 PM UTC.

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